REACH

1. REACH The proposed legislation

2. The Current EU Chemicals Policy Problems • Existing substances can be used without testing • Burden of proof on public authorities • No efficient instrument to deal with problematic substances • Lack of incentives for innovation, in particular of less hazardous substitutes Burden of the Past

3. A New EU Chemicals Policy Objectives • Sustainable Development • Protection of human health and the environment • Maintain/enhance innovation/competitiveness • Maintain the Internal Market • Increased transparency and consumer awareness • Integration with international efforts • Promotion of non-animal testing Guiding Principles - substitution and precaution

4. The REACH System One System • Single, coherent system for new/existing chemicals • Three new elements: • Registration • Evaluation • Authorisation • Focus on substances: • high volumes • of greatest concern. A Tiered Approach

5. REACH - White Paper Registration Evaluation Authorisation > 100 tonnes. (+ priority) CMR (cat 1&2) POPS > 1 tonne plus Restrictions Central Entity

6. And in practice? New Responsibilities • Industryresponsible for generating the knowledge • Downstream users - assess the safety of their products • Member StateAuthorities responsible for evaluating data submitted under Registration • New Agency - technical, scientific and administrative framework Reversed Burden of Proof

7. REACH - since the White Paper? • Duty of care • Pre-registration • Registration • intermediates • polymers • Authorisation • PBTs, vPvBs, ‘Other substances’ • Agency Council Conclusions European Parliament Working groups Studies

8. Duty of care • Manufacturers/Importers/Downstream users: • manufacture/use of substance • reasonably foreseeable conditions • health/environment not adversely affected. • Chemical Safety Assessment (Downstream user assessment) • Chemical Safety Report • Updated • Transmitted through supply chain

9. Registration Industry demonstrate chemicals managed safely • Substances produced/imported > 1 tonne/year • Phased approach

10. Registration of Chemicals: A Phased Approach 1 - 10 t >1000 t + CMR 100 - 1000 t 10 - 100t Yr 0 Yr 0 +3 Yr 0 + 6 Yr 0 + 11

11. Registration Industry demonstrate chemicals managed safely • Substances produced/imported > 1 tonne/year • Phased approach • Central data base run by an independent agency • Information requirements increase with volume • > 100 tonnes testing proposals • Intermediates/polymers - reduced requirements • Updated - new information

12. Evaluation Confidence that industry is meeting obligations Prevent unnecessary testing • Data examined by Competent authorities. • Standard (>100 tonnes) - testing proposals • Priority (concern about risks) • Additional information/testing can be required. • “Mutual recognition” system

13. Authorisation (1) Control uses of very high concern substances • Very high concern? • CMR, PBT, vPvB, ‘Substances of equivalent concern’ • produced/sold for specific uses/under certain conditions – for supply chain. • may include a review period. • Applicant to show: • adequate control of risks, or • social and economic benefits outweigh the risks. • Substitution considered • Prioritised.

14. Authorisation (2) • How does the Water Framework Directive fit in? • Current draft: • risks to health and environment from emission to aquatic compartment not considered if binding emission limit or eqs in a permit granted in accordance with 2000/60/EC. • Still under discussion

15. Restrictions Safety net • Community concern • For manufacture/marketing/use • MS (or Com) initiate • Dossier (MS) to justify • RA and SEA produced – Committee opinion • Transparency via website • Commission proposal – commitology.

16. Who does what?

17. Stakeholder concerns • High costs • Increased animal testing • Impact on downstream users • Production moving outside the EU • EU industry disadvantaged internationally • Loss of marketed substances

18. Costs • Business Impact Assessment study 2002: • Direct costs: €1.4—7 billion; most likely € 3.6 billion. • less than 0.1 % of yearly turnover over 11 years. • Proposal adapted • e.g. less data on intermediates, greater scope to waive testing • will now revise the study • Indirect costs: under assessment • 90 % of costs from testing • Industry has very little information about its chemicals? • The knowledge gap REACH is designed to fill

19. Benefits (1) • For new and existing substances, equivalent: • levels of protection • competitive advantages (Ex:hazardous v Nw: non-hazardous) • > 30,000 existing substances investigated • Acute (and long-term) toxicity • Improved innovation • more R&D flexibility • no significant loss of protection • Testing requirements: 1 - 10 tonnes generally in-vitro

20. Benefits (2) • Benefits: occupational health, public health & environment • Occupational Health Study • Commission will publish a study today • benefits estimated at between €18 and 54 billion • Public health study underway • initial results suggest substantial benefits • Environmental benefits hard to express in cash terms • reduced pollution of air, water, soil, reduced pressure on biodiversity Conclusion: benefits significantly outweigh costs

21. Limit animal testing • Information requirements - smart/targeted: • exposure often taken into account. • not always necessarily to do new testing (eg (Q)SAR). • Low volume production/import chemicals (1-10 tonnes/year): • as far as possible no animal testing. • For higher volumes: • testing only if existing information/validated alternative methods not sufficient. • Testing programmes - decided by the competent authorities • Data sharing encouraged, but eventually compulsory; fair cost sharing. REACH = large-scale information collection, = large-scale testing.

22. Timing • Internet consultation • May - July 2003 • Focused on workability • www.europa.eu.int/comm/environment/chemicals/whitepaper.htm • Adoption • Planned - autumn 2003 • Council and Parliament

23. Conclusions - REACH • High level of protection • Changing burden of proof • Improved knowledge • Encourage innovation • Substitution of most dangerous substances • Better: • tracking of chemicals • use of resources • reaction to emerging risks • information for downstream users • better consumer confidence Benefits significantly outweigh costs